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FDA 510(k)

GE DATEX-OHMEDA AVANCE

K-Number: K081844 · 2008-08-29

ApplicantDatex-Ohmeda, Inc.
Decision Date2008-08-29
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

GE DATEX-OHMEDA AVANCE is the device name listed in this FDA 510(k) record. The listed applicant is Datex-Ohmeda, Inc.. It received FDA 510(k) clearance on 2008-08-29 under 510(k) number K081844. The device is classified under product code BSZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GE DATEX-OHMEDA AVANCE?

GE DATEX-OHMEDA AVANCE is a medical device that received FDA 510(k) clearance on 2008-08-29. The listed applicant is Datex-Ohmeda, Inc.. The 510(k) number is K081844.

When did GE DATEX-OHMEDA AVANCE receive FDA 510(k) clearance?

GE DATEX-OHMEDA AVANCE received FDA 510(k) clearance on 2008-08-29, under 510(k) number K081844.

Who is the listed applicant for GE DATEX-OHMEDA AVANCE?

The FDA 510(k) record lists Datex-Ohmeda, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GE DATEX-OHMEDA AVANCE?

The FDA product code for GE DATEX-OHMEDA AVANCE is BSZ.

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Related Devices (Code: BSZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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